About this medication

What the medication is used for

STIVARGA is used to treat colon or rectal cancer that has spread to other parts of the body in patients who have already received other treatments (fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy).

STIVARGA is used to treat gastrointestinal stromal tumors (GIST) that have spread to other parts of the body or are not treatable with surgery in patients who have already received treatment with imatinib and sunitinib.

What it does

STIVARGA works by slowing down the growth and spread of cancer cells and cutting off the blood supply that keeps cancer cells growing.

When it should not be used

Do not take STIVARGA if you are allergic (hypersensitive) to regorafenib or sorafenib or any of the other ingredients of STIVARGA.

What dosage forms it comes in

Film-coated 40 mg tablets in bottles of 28 tablets.

Warnings and precautions

Serious Warnings and Precautions

Treatment with STIVARGA may lead to:— Liver problems which may cause death.—Bleeding problems which may cause death.— Chest pain or heart problems.— Headache, confusion, seizures and visual loss.— Severe bowel problems.— High blood pressure.— Redness, pain, swelling, or blisters on the palms of your hands and soles of your feet.

BEFORE you use STIVARGA talk to your doctor if you have or have had any of the following conditions:

Liver disease with yellowish discoloration of the skin and the whites of the eyes (jaundice), dark urine, confusion and/or disorientation. Treatment with STIVARGA may lead to a higher risk of liver problems. Prior to and during the treatment with STIVARGA your doctor will do blood tests to monitor your liver function.

Any bleeding problems or if you are taking warfarin or a medicine that thins the blood to prevent blood clots. Treatment with STIVARGA may lead to a higher risk of bleeding. Before you start treatment your doctor may decide to do blood tests.

Heart problems. Before you start STIVARGA and during treatment your doctor will check how well your heart is working.

High blood pressure. STIVARGA can raise your blood pressure, and your doctor will monitor your blood pressure prior to and during the treatment and may give you a medicine to treat high blood pressure. If you develop severe and persistent headache and/or visual disturbances contact your doctor immediately.

Skin problems. STIVARGA can cause redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you notice any changes be sure to contact your doctor. To manage your symptoms, your doctor may recommend the use of creams and/or the use of shoe cushions and gloves. If you get this side effect, your doctor may change your dose or temporarily stop your treatment until this skin condition improves.

Upcoming surgery. STIVARGA might affect the way your wounds heal and treatment may need to be stopped until your wound heals.

You are pregnant, or you or your partner could become pregnant. Your doctor will discuss with you the risks and benefits of using STIVARGA during pregnancy. Reliable birth control should be used by both males and females and for 8 weeks after the last dose of STIVARGA.

You are breastfeeding. Do not use STIVARGA if you are breastfeeding.

STIVARGA should not be given to patients under 18 years of age.

Interactions with this medication

Tell your doctor about all the medicines you take, including prescription and non -prescription medicines, vitamins, and herbal supplements. STIVARGA may affect the way other medicines work, and other medicines may affect how STIVARGA works. You may need to change the dosage or stop taking one of the medicines.

See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

Proper use of this medication

Usual dose

The recommended daily dose in adults is four STIVARGA 40 mg tablets (160 mg of regorafenib). Your doctor may change your dose. Take the dose of STIVARGA that your doctor prescribes for you.

Take STIVARGA at the same time each day after a light (low fat) meal. An example of a low-fat, low-calorie meal is two slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly and 8 ounces of skim milk (approximately 319 calories and 8.2 grams of fat). The tablets should be swallowed whole with water.

Overdose

In case of drug overdose, contact your doctor, or a poison control center, or go to the emergency room of the hospital near you immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, take it as soon as you remember on that day. Do not take two doses of STIVARGA on the same day to make up for a missed dose from the previous day. Tell your doctor about any missed dose.

How long will I take STIVARGA

Your doctor will usually ask you to take STIVARGA for 3 weeks and then to stop for 1 week. This is 1 cycle of treatment. Your doctor may need to reduce your dose or may decide to interrupt or discontinue the treatment permanently if necessary. You will usually take STIVARGA as long as you are benefitting from treatment and not suffering unacceptable side effects.

Side effects and what to do about them

STIVARGA can have side effects, like all medicines, but not everybody gets them. For further information about any of these effects, ask a doctor or pharmacist. If you experience any symptom that bothers you or does not go away, or you develop a severe side effect such as high blood pressure, bleeding or skin reactions, contact your doctor or seek medical attention as soon as possible.

The most common side effects of regorafenib may include:

tiredness, fatigue

loss of appetite

rash, redness, itching or peeling of your skin

diarrhea (frequent or loose bowel movements)

weight loss

infections

increase in blood pressure

voice changes or hoarseness

Tell your healthcare provider right away, if you get high fever, nausea, vomiting or severe abdominal pain.

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada website at: www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of the side effect, please contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

For more information, please contact your health professional or pharmacist first, or Bayer Medical Information at 1-800-265-7382 or canada.medinfo@bayer.com.

This document plus the full Product Monograph, prepared for health professionals can be found at: http://www.bayer.ca or by contacting the manufacturer at the above-mentioned phone number and email address.